HIGHFDA DEVICE

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC

Resorbable bone void filler falls outside standard specifications.

Orthorebirth CoHealth & Personal CareMedical DevicesUDI-DI: 04573190050552. Lots: 250430012504300225043003

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 25, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 25, 2026
Hazard Level
HIGH
Brand
Orthorebirth Co
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Orthorebirth Co
Model numbers
UDI-DI: 04573190050552. Lots: 25043001, 25043002, 25043003, 25051401, 25051402, 25051701, 25051702, 25060701 +12 more
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 25, 2026

  2. Reported by FDA DEVICE

    May 13, 2026

  3. RecallRadar source check

    May 20, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Resorbable bone void filler falls outside standard specifications.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthorebirth Co Ltd or your healthcare provider for instructions

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Full Description

BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC. Reason: Resorbable bone void filler falls outside standard specifications.. Classification: Class II. Quantity: 1266. Distribution: US Nationwide distribution in the states of CA, FL.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
UDI-DI: 04573190050552. Lots: 25043001
25043002
25043003
25051401
25051402
+15 more
Affected States
ALL
Report Date
May 13, 2026
Recall Status
ACTIVE